Job Description To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
- Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
- Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values.
- Identify and protect the original technical information as part of the company property.
Key responsibilities
- Develop and implement Core Lab strategic narratives, aligning with cross-functional teams and leading Core Lab initiatives.
- Install, configure, and optimize hardware, software, and communication links while ensuring minimal downtime. Diagnose, resolve, and document hardware and software problems in a timely and accurate fashion, and provide end user training and support as needed.
- Maintain Active Directory and Group policies, deploy servers, patch management, Perform backups and server monitoring checks.
- Support, Maintenance and User Administration of local Laboratory applications which will include Periodic System Reviews and System Audit Trail Reviews.
- Provide front line support (level 1) to labs. Troubleshoot system errors and collaborate with vendor/global teams for resolution.
- Act as main point of contact on site for Laboratory System Helpdesk which will include interacting with the Global system teams or system vendors on various system issues.
- Providing appropriate system access to vendors.
- Support system content deployment and end user training.
- Recognizing the importance of the Quality control, Analytics and Process Development functions in pharmaceutical production, the IT Application and Lab Systems Specialist should display a high level of integrity in the performance of their work.
- Take ownership of issues seeing it through from beginning to end.
- Assist in deployment, monitoring, maintenance, data backup, documentation, upgrade, and support of all IT systems. This includes all servers, e-mail, PCs, phone systems, hardware, software, mobile devices, peripherals, switches, routers, cabling, and all associated operating systems and software.
- Support LANs, WANs, Internet and Intranet Systems
- Administration of GMP software as per regulatory requirements (21 CFR Part 11 and cGMP).
- Receive and respond to help desk tickets, phone requests, and/or e-mails regarding IT issues.
- Perform on-site analysis, diagnosis, and resolution of IT issues for a variety of end users and recommend and implement corrective hardware and software solutions.
- Stays up to date with external best practices and the latest process and technology advancements in the field and uses this knowledge to develop and maintain role capability.
- Prepare and ensure accuracy of documentation, end user binders, procedures, and manuals.
QualificationsEducation / Experience
- Bachelor's degree in an IT or scientific field (e.g., Chemistry, Biology, Business Information Systems).
- Minimum five (5) years' work-related experience.
- Settled knowledge in Lab and QA systems such as labware LIMS, Agilent OpenLab CDS, Tiamo, TGA, XRPD, and/or similar systems in a GxP environment.
- Business partnering and communication skills.
- Service Management expertise
- Working technical knowledge of VMware, backup software, databases, networks, servers, and PC operating systems.
Job Competencies
- Ability to conduct research into networking issues and products as required; disseminate information as needed in a user-friendly language.
- Knowledge of applicable data privacy practices and laws.
- Strong problem-solving skills.
- Excellent communication and interpersonal skills are essential.
- Excellent organizational and prioritization skills
- Ability to work well both independently and in a team environment.
- Ability and flexibility to perform all other job-related and ad-hoc duties as required.
- Able to multi-task and meet demands of customers.
- Follow FDA, EPA, OSHA, GMP and 21 CFR Part 11 regulations.
- Willing to work off-shift times, as necessary, to complete projects.